NCT01323426

Brief Summary

This pilot study examines safety and efficacy of a simple procedure for treatment of stress urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the urethral sphincter.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

3.3 years

First QC Date

March 21, 2011

Last Update Submit

January 23, 2013

Conditions

Urinary Incontinence, Stress

Keywords

urinary incontinence, stressautologous

Outcome Measures

Primary Outcomes (1)

  • Frequency of incontinence episodes

    Reduction in the number of leakages in three days

    12 months

Secondary Outcomes (4)

  • International Consultation on Incontinence (ICIQ)short form incontinence score

    12 months

  • Intraurethral pressure measured by reflectometry

    12 months

  • Uroflow

    12 months

  • Adverse events peri- or postoperatively

    12 months

Study Arms (1)

periurethral injection

EXPERIMENTAL

Periurethral injection of autologous muscle fibers

Procedure: Periurethral injection

Interventions

Periurethral injectionPROCEDURE

Periurethral injection of autologous muscle fibers

periurethral injection

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stress urinary incontinence refractory to conservative treatment.

You may not qualify if:

  • urge urinary incontinence
  • Pregnancy
  • Pelvic organ prolapse \> grade 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Søren Gräs, MD

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 25, 2011

Study Start

May 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

DK(1)